Keep Social Study for Young Adults

Not Applicable

• Conditions: Loneliness; Social Isolation

• Registration Number: NCT07005817
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The Keep Social randomized control trial (RCT) is a 6-week, online study which will test whether, relative to a placebo control condition, an intervention that encourages high-quality in-person social interactions with strangers and acquaintances reduces young adults' (ages 18 - 29) social isolation and loneliness.

Participants will complete our 6-week protocol, which includes 6 weeks of passive ecological behavior sampling (i.e., geotracking) and Day Reports, our 4-week Invibe social media messages, plus recurrent Biweekly Assessments (BW1-BW4) that include both self-reported and behavioral measures. The first Monday following enrollment, participants complete the BW1 baseline survey to assess demographic characteristics and initial levels of all outcome variables (primary and secondary, \~20 min). They also (optionally) activate passive geotracking on this day and leave it activated, continuously, for the duration of the study.

During the 2-week baseline and 4-week Invibe phases, time-varying psychological and behavioral mediators and moderators will be assessed three times per week via Day Reports. To increase ecological validity, each week, two weekdays (i.e., Monday, Tuesday, Wednesday, or Thursday), and one weekend day (i.e., Friday, Saturday or Sunday) will be randomly selected. Day reports will not be assigned on Mondays if there is a biweekly assessment scheduled.

Detailed Description

Social isolation and its subjective counterpart loneliness-well established as risk factors for poor physical and mental health-have been rising at alarming rates in the US, especially among young adults. Mechanistic understanding of how best to build social connectedness to ameliorate social isolation is sorely needed to redirect life trajectories toward health and well-being. In creating this foundational knowledge, variations across individuals and geographic location merit focus because these variations may be associated with unique challenges and opportunities for initiating social interactions. The broad, overarching objective of this work is to conduct basic experimental research on social connectedness to test whether, how, where, and for whom health communication messages can motivate in-person interactions to reduce young adults' social isolation and loneliness. Our multi-disciplinary team brings together expertise in social psychology, emotion science, communication science, and public health and will carry out a 6-week randomized controlled trial-the Keep Social RCT-using our innovative and ecologically valid simulated social media platform and a suite of rigorous repeated measures of social behavior, loneliness, and other health relevant outcomes.

This program of research is designed to meet three specific aims. SPECIFIC AIM 1 is to use optimized health messages about the value of social connectedness for young adults (ages 18-29) to conduct the Keep Social RCT to build a rich empirical platform. Initial empirical work has already used a human-centered process to design health communication messages that included peer imagery and stories and tested them in an online experiment with \>700 young adults. Messages that received the highest ratings for encouraging in-person interactions in this online experiment were selected for the Keep Social RCT, which is placebo-controlled with behavioral and survey assessments repeated over six weeks. SPECIFIC AIM 2 is to analyze theory-driven mechanisms through which health communication messages in the Keep Social RCT may reduce young adults' social isolation and loneliness to identify intervention targets. This aim will be met with longitudinal statistical modeling to test whether and how the experimental health communication messages improve social connectedness. SPECIFIC AIM 3 is to extend data analyses of the Keep Social RCT to identify moderators of reduced social isolation and loneliness to identify where and for whom effects are largest. This aim will be met with advanced statistical modeling to illuminate the conditions under which our health communication messages most effectively ameliorate social isolation and loneliness in young adults. Taken together, this research will provide a framework to identify intervention targets to guide subsequent translational work undertaken to reduce loneliness that has been increasing across the US.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study Start: 2025-05-19
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-05
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-08
• Primary Completion: 2027-11
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

• Use social media
• Own a smartphone
• Reside in urban or suburban regions
• Meet one or more criteria for membership in a sociodemographic population with increased risk of adverse health outcomes in the U.S.: at least 500 participants who identity as Black or African American, at least 500 participants who identify as Hispanic, at least 500 participants with low subjective social status - i.e., who report a 5 or lower on the MacArthur Subjective Social Status (SSS) ladder). Groupings are not mutually exclusive.

Exclusion Criteria

• Reside in rural region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quantity of locations visited as a potential indicator of social opportunity	Continuous over the duration of the 6-week study	Participants will be asked to download a geolocation app to their smartphone that tracks their physical location throughout the study. Number of locations visited is a count variable (integers), with a lower bound of zero and an upper bound to be determine by participant behavior.
Roaming entropy as a potential indicator of social opportunity	Continuous over the duration of the 6-week study	Based on GPS data (i.e., coordinates and timestamps), roaming entropy (RE) scores are computed with RE higher for days where one visits a greater number of locations and exhibits greater uniformity in the time distribution across visited locations. A minimum RE value would be achieved by spending all day in a single location, whereas maximum RE would, theoretically, be achieved by spending an equal proportion of the day in each unique location in an environment. Possible range is 0.00 to 1.00; range in past datasets is 0.00 to 0.52.
Loneliness, Self-Report (Biweekly)	Baseline/Week 0, Week 2, Week 4, and Week 6	Four items from the National Institute of Health (NIH) Toolbox Adult Social Relationship Scales with mean responses ranging from 1 to 5. Lower scores indicate reduced loneliness.
Loneliness, Self-Report (Day)	Included in Day Reports, 3 times a week, over the 6-week RCT	One item: "Today, I felt lonely." Mean scores range from 1 to 7 with a lower score representing less loneliness.
Behavioral Motivational Value for Strangers-Smiling-with-Direct-Gaze	Week 4	The behavioral measure of motivational value (a.k.a., Implicit Motivational Value, or iMV) is estimated in a choice task as k values for stimulus types using a reinforcement learning (RL) paradigm and computational approaches. The task stimuli include fractals that precede the presentation of headshot photos of unfamiliar others in the same age range as study participants. Those photos show persons with one of 3 facial expressions: smiling-with-direct-gaze, smiling-with-gaze-averted, and neutral-with-gaze-averted. Participants are instructed to select their preferred fractal.; Following work by Waugh et al. Computational a priori starting range: -1.5 to 1.5, with higher means representing more motivation to experience the image type (e.g., strangers-smiling-with-direct-gaze) relative to the middle category (i.e., strangers-smiling-with-gaze-averted).
Social Connection, Open Text	Week 6	Participants will respond to an open-ended writing prompt asking them to reflect on how socially connected (or not) they felt during the study.; To index both loneliness and depression, both top-down (theory-driven) dictionary-based approaches, specifically the Linguistic Inquiry Word Count (LIWC) and also bottom-up (data-driven) open-vocabulary linguistic features (words, phrases, and topics) will be used. LIWC scores represent the relative frequency of designated words within each LIWC category, ranging from 0.0 to 1.0. Higher scores represent greater frequency of the designated word category.; Latent Dirichlet Allocation modeling (LDA) will be used to generate "topics" that represent data-driven linguistic features. The investigators will compute the topic distribution of each participant, ranging from 0.0 to 1.0. Higher scores represent greater frequency of the designated topic.

Secondary Outcome Measures

Name	Time	Method
Anxiety, Self-Report	Baseline/Week 0, Week 2, Week 4, and Week 6	4-item Patient Reported Outcomes Measurement Information System (PROMIS)-29 measure that assesses participants' frequency of experiencing symptoms of anxiety. As described in the statistical analysis plan, the investigators plan to use the anxiety measure as an indicator in a "negative mental health" latent variable. Mean scores range from 1 to 7 with a lower score representing less anxiety.
Depression, Self-Report	Baseline/Week 0, Week 2, Week 4, and Week 6	4-item PROMIS-29 measure that assesses participants' frequency of experiencing symptoms of depression. As described in the statistical analysis plan, the investigators plan to use the depression measure as an indicator in a "negative mental health" latent variable. Mean scores range from 1 to 7 with a lower score representing fewer symptoms of depression.
Stress, Self-Report	Baseline/Week 0, Week 2, Week 4, and Week 6	4-item PROMIS-29 measure that assesses participants' frequency of perceiving stress. As described in the statistical analysis plan, the investigators plan to use the measure of perceived stress as an indicator in a "negative mental health" latent variable. Mean scores range from 1 to 7 with a lower score representing decreased stress levels.
Flourishing Mental Health, Self-Report	Baseline/Week 0, Week 2, Week 4, and Week 6	14 items from the Mental Health Continuum, Short Form (MHC-SF) assessing flourishing mental health (emotional, psychological, and social well-being). As described in the statistical analysis plan, the investigators plan to use the MHC-SF measure as an indicator in a "positive mental health" latent variable. Scale scores range from 0 to 4 with higher scores used as a proxy for "positive mental health".
Life Satisfaction, Self-Report	Baseline/Week 0, Week 2, Week 4, and Week 6	5-item NIH PROMIS survey that assesses participants' frequency of experiencing satisfaction with their life from PROMIS v1.0 -General Life Satisfaction Short Form 5a. As described in the statistical analysis plan, the investigators plan to use the life satisfaction measure as an indicator in a "positive mental health" latent variable. Mean scores range from 1 to 7, with higher scores representing life satisfaction.
Belongingness, Self-Report	Baseline/Week 0, Week 2, Week 4, and Week 6	12-item General Belongingness Scale which assesses participants' sense of belonging across multiple levels of social ties and an overall sense of belonging beyond all interpersonal relationships. Mean scores range from 1 to 7 with higher scores indicating a greater sense of belonging.
Alcohol Consumption	Week 2 and Week 6	Four items from the CDC's Behavioral Risk Factor Surveillance System (BRFSS) assess the frequency and quantity, respectively, of participants' consumption of alcoholic drinks during the past 30 days. The average daily alcohol consumption is calculated by multiplying the number of drinking days per month, as reported by each drinker, by the average number of drinks consumed per drinking day by each drinker; and then the product of the average total number of drinks consumed by all drinkers is divided by 30 days.
Illness Symptoms, Self-Report	Included in Day Reports, 3 times a week, over the 6-week RCT	Participants asked to report the extent to which they experienced illness symptoms on the day they took their survey using the following item: "Today, I felt physically unwell or under the weather." Mean scores range from 1 to 7, with higher scores representing a greater degree of illness.
Physical Pain, Self-Report	Included in Day Reports, 3 times a week, over the 6-week RCT	One item asks participants the degree to which they felt impeded by bodily sensations of physical pain that day: "Today, I was bothered by physical pain." Mean scores range from 1 to 7, with higher scores indicating more pain.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States